Label: GILTUSS CHILDRENS COUGH AND COLD- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution
- NDC Code(s): 65852-011-04
- Packager: Dextrum Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 17, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
-
Use section
Uses * temporary relieves* cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants*
the intensity of coughing**the impulse to cough to help your child get to sleep* helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes*temporary relieves nasal congestion due to a cold*stuffy nose
-
Warnings
Donot use if your child is now taking a prescription monoamine oxidase inhibitor (MAOI) ( certain drugs for deppresion, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your's child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this oroduct.

-
Ask a doctor
Ask a doctor before use if your child has *heart desease, high blood pressure, thryroid desease, diabetes* a cough with too much phlegm ( mucus)* a persistent or chronic cough as occurs with asthma or chronic bronchitis
Ask a doctor or pharmacist before use if your child is taking any other nasal descongestant or stimulant, sedatives, tranquilizer, andndrugs used for depression, especially monoamine oxidase inhibitors (MAOIs)* When using this product do not use more than directed
Stop use and ask a Doctor if * nervousness,dizziness or sleeplesness occur* sympton do not get better within 7 days or are accompanied by fever* cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent haedache . These could be signs of serious conditions.
- PREGNANCY OR BREAST FEEDING
-
Directions and other information
Directions* no take more than 6 doses in any 24 hours period * use enclosed dosing cup* keep dosage cup for use with this product* ml= mililiter
Children under 4 years ----Consult a doctor
children 4 to under 6 years------1.25 ml every 4 hours
children 6 to under 12 years-----2.5 ml every 4 hours
children 12 yeras and over -------5 ml every 4 hours
Other information
store at room temperature 15 - 30 0c* close cap tightly* save carton for complete drug facts

- Questions section
- Active ingredients section
- Inactive Ingredients
- Keep out of reach of children
-
Indication and Usage section
Indication and Usage section
no take more than 6 doses in any 24 hours period
use enclosed dosing cup* keep dosage cup for use with this product* ml= mililiter
Children under 4 years ----Consult a doctor
children 4 to under 6 years------1.25 ml every 4 hours
children 6 to under 12 years-----2.5 ml every 4 hours
children 12 yeras and over -------5 ml every 4 hours

- Purpose sectiion
- Principal panel
-
INGREDIENTS AND APPEARANCE
GILTUSS CHILDRENS COUGH AND COLD
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65852-011 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg in 2.5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 2.5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 150 mg in 2.5 mL Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) GLYCERIN (UNII: PDC6A3C0OX) PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBITOL SOLUTION (UNII: 8KW3E207O2) CITRIC ACID (UNII: 2968PHW8QP) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65852-011-04 1 in 1 CARTON 11/07/2018 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 11/07/2018 Labeler - Dextrum Laboratories Inc. (007392322)



